IMG-7289 in Patients With Myelofibrosis
This is a Phase 2b open label study of an orally administered LSD1 inhibitor, IMG-7289, in patients with myelofibrosis.
This study investigates the following:
The safety and tolerability of IMG-7289
The pharmacokinetics of IMG-7289 (performed in Phase 1/2a only)
The pharmacodynamic effect of IMG-7289
|Condition or Disease||Intervention/Treatment||Phase|
With enrollment complete in Phase 1/2a, expansion into Phase 2b has occurred. New patients will be enrolled into Phase 2b study.
Arms and Interventions
Single starting dose with individualized dose titrations throughout
Primary Outcome Measures
- Incidence of treatment-emergent adverse events, and changes in physical examination, vital signs and laboratory parameters [safety and tolerability] [Assessed from the time of first dose through 28 days after end of treatment.]
as measured by the frequent monitoring of: adverse events, physical examination and vital signs and laboratory parameters.
Secondary Outcome Measures
- Drug Concentration (performed in Phase 1/2a only) [Up to 3 months.]
as measured by Cmin sampling.
- Spleen Volume [Baseline to each visit where the variable is measured.]
Reduction in spleen volume based on MRI (or CT)
Diagnosis of either PMF per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms, PPV-MF or PET-MF per the IWG-MRT
High or intermediate-2 risk disease, as defined per protocol
Receiving other treatments for the condition (with exceptions and time limits)
Major surgery in last 4 weeks, minor surgery in the last 2 weeks
History of, or scheduled, hematopoietic stem cell transplant within 24 weeks of Screening
History of splenectomy
Current use of prohibited medications
A concurrent second active and nonstable malignancy
Known HIV infection or active Hepatitis B or Hepatitis C virus infection
Other hematologic/biochemistry requirements, as per protocol
Use of investigational agent within last 14 days
Pregnant or lactating females
Contacts and Locations
|1||University of Michigan||Ann Arbor||Michigan||United States||48105|
|2||Royal Adelaide Hospital||Adelaide||South Australia||Australia|
|4||Azienda Ospedaliero Universitaria Careggi||Florence||Italy|
|5||Guy's and St Thomas' Hospitals||London||United Kingdom|
Sponsors and Collaborators
- Imago BioSciences,Inc.
- Principal Investigator: Kristen Pettit, University of Michigan
Study Documents (Full-Text)None provided.